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06975409760029

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou LongGene Scientific Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000024510
UDI-DI: 06975409760029
Basic UDI-DI: 6975409760005DD
Reference: Q2000B
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: MedPath GmbH
Last updated: 16.06.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

06975409760036

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou LongGene Scientific Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000024510
UDI-DI: 06975409760036
Basic UDI-DI: 6975409760005DD
Reference: Q2000C
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: MedPath GmbH
Last updated: 16.06.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

06975409760043

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou LongGene Scientific Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000024510
UDI-DI: 06975409760043
Basic UDI-DI: 6975409760005DD
Reference: Q1000
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: MedPath GmbH
Last updated: 16.06.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

06975409760050

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou LongGene Scientific Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000024510
UDI-DI: 06975409760050
Basic UDI-DI: 6975409760005DD
Reference: Q1000+
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: MedPath GmbH
Last updated: 16.06.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

06975409760067

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou LongGene Scientific Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000024510
UDI-DI: 06975409760067
Basic UDI-DI: 6975409760005DD
Reference: Q160
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: MedPath GmbH
Last updated: 16.06.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

06975409760074

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou LongGene Scientific Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000024510
UDI-DI: 06975409760074
Basic UDI-DI: 6975409760005DD
Reference: Q160A
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: MedPath GmbH
Last updated: 16.06.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

06975409760081

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou LongGene Scientific Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000024510
UDI-DI: 06975409760081
Basic UDI-DI: 6975409760005DD
Reference: Q160B
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: MedPath GmbH
Last updated: 16.06.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

06975409760098

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou LongGene Scientific Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000024510
UDI-DI: 06975409760098
Basic UDI-DI: 6975409760005DD
Reference: Q160C
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: MedPath GmbH
Last updated: 16.06.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

Galaxy Pro

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Igenesis(Shanghai)Co.,Ltd.
Manufacturer SRN: CN-MF-000001552
UDI-DI: 06975447581037
Basic UDI-DI: 697544758GALAXYU9
Reference: 101-0037-01
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 12:30

Manufacturer products Authorised representative products Authorised representative actors View details

Galaxy Lite

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Igenesis(Shanghai)Co.,Ltd.
Manufacturer SRN: CN-MF-000001552
UDI-DI: 06975447581044
Basic UDI-DI: 697544758GALAXYU9
Reference: 101-0038-01
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 12:30

Manufacturer products Authorised representative products Authorised representative actors View details

Galaxy Neo

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Igenesis(Shanghai)Co.,Ltd.
Manufacturer SRN: CN-MF-000001552
UDI-DI: 06975447581068
Basic UDI-DI: 697544758GALAXYU9
Reference: 101-0062-01
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 12:30

Manufacturer products Authorised representative products Authorised representative actors View details

Thermal Cycler&Real-time PCR

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Infitek Co., Ltd.
Manufacturer SRN: CN-MF-000040107
UDI-DI: 06975488440072
Basic UDI-DI: 697548844PCR22T5
Reference: PCR-Q16-1B
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 16.06.2026 12:29

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Infitek Co., Ltd.
Manufacturer SRN: CN-MF-000040107
UDI-DI: 06975488440942
Basic UDI-DI: 697548844PCR22T5
Reference: PCR-Q96-6
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 16.06.2026 12:29

Manufacturer products Authorised representative products Authorised representative actors View details

06979502241478

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06979502241478
Basic UDI-DI: 697950224PCR1116016E
Reference: PCR111601
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 16.06.2026 11:25

Manufacturer products Authorised representative products Authorised representative actors View details

GeneXpert®

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940007690
Basic UDI-DI: 081164701-GX-X5
Reference: GeneXpert IV (GX-IV)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Cepheid AB
Last updated: 16.06.2026 10:31

Manufacturer products Authorised representative products Authorised representative actors View details

GeneXpert®

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940007706
Basic UDI-DI: 081164701-GX-X5
Reference: GeneXpert XVI (GX-XVI)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Cepheid AB
Last updated: 16.06.2026 10:31

Manufacturer products Authorised representative products Authorised representative actors View details

GeneXpert®

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940007720
Basic UDI-DI: 081164701-INFINITY-ZH
Reference: GX-INFINITY 80
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Cepheid AB
Last updated: 16.06.2026 10:31

Manufacturer products Authorised representative products Authorised representative actors View details

GeneXpert®

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940009687
Basic UDI-DI: 081164701-GX-X5
Reference: GeneXpert XVI-RS
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Cepheid AB
Last updated: 16.06.2026 10:31

Manufacturer products Authorised representative products Authorised representative actors View details

GeneXpert®

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940009694
Basic UDI-DI: 081164701-GX-X5
Reference: GeneXpert IV (GX-IV)-RS
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Cepheid AB
Last updated: 16.06.2026 10:31

Manufacturer products Authorised representative products Authorised representative actors View details

PGDx elio tissue complete

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentKitProfessional testingReagent

Manufacturer: Personal Genome Diagnostics, Inc.
Manufacturer SRN: US-MF-000026862
UDI-DI: 00192721001487
Basic UDI-DI: 0192721U0200100NL
Reference: -
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 28.05.2026 22:01

Manufacturer products Authorised representative products Authorised representative actors View details